Kezar to discontinue mid-stage trial for lupus treatment (updated)

Kezar Life Sciences

17/10/2024 14:29

(Adds details and background in paragraphs 2-7, share movement
in paragraph 8)
       Oct 17 (Reuters) - Kezar Life Sciences  KZR.O  said on
Thursday it would terminate its mid-stage trial studying its
experimental drug in patients with active lupus nephritis and
focus on developing the drug for a rare chronic disorder called
autoimmune hepatitis.
    Earlier this month, the U.S. Food and Drug Administration
placed a clinical hold on the trial of the drug, zetomipzomib,
studying it in patients with active lupus nephritis, which
causes inflammation and damage in the kidneys due to a form of
immune-related condition called lupus.
    The regulator's decision came after the company paused the
study in September to review safety data following the deaths of
four patients.
    An independent study committee had recommended a pause on
the trial after it found that three of the fatalities showed a
common pattern of symptoms and the deaths happened close to the
time of dosing, while a non-fatal adverse event also showed a
similar proximity to the dosing time.
    Kezar said it would continue its mid-stage trial in patients
with autoimmune hepatitis, a disease in which the immune system
attacks the liver and causes inflammation and tissue damage,
without modification after the review of an independent
committee.
    Till date, no serious adverse events have been observed in
the trial, Kezar said.
    Separately, Kezar said its board has rejected Concentra
Biosciences' proposal to buy the company's outstanding shares
for $1.10 apiece in cash.
    Shares of the company fell about 16% to 75 cents in
premarket trading.
    

 (Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi
Majumdar)
 ((Sriparna.Roy@thomsonreuters.com;))